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Clinical Trial Details

Trial ID: L4587
Source ID: NCT05804513
Associated Drug: Placebo
Title: The Effect of Lixisenatide on the Effect of Pituitary Hormones
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Healthy|Type 1 Diabetes
Interventions: DRUG: Placebo|DRUG: Lixisenatide 10 micrograms (50 micrograms/ml in 3 ml) Pen Injector
Outcome Measures: Primary: Growth hormone area under the curve., Treatment effect (placebo vs lixisenatide) on growth hormone area under curve (AUC) is compared between patients with type 1 diabetes and healthy volunteers., 0-150 minutes after study drug administration | Secondary: Growth hormone peak, Maximum growth hormone concentration measured after study drug administration., 30, 60, 90, 120, and 150 minutes after the study drug administration.|Glucose nadir, Lowest glucose concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration|C-peptide peak, Maximum c-peptide concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration|Cortisol peak, Maximum cortisol concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration|Adrenocorticotropic hormone (ACTH) peak, Maximum ACTH concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration|Prolactin peak, Maximum prolactin concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration|Copeptin peak, Maximum copeptin concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration|Aldosterone peak, Maximum aldosterone concentration measured after the study drug administration, 30, 60, 90, 120, and 150 minutes after the study drug administration | Other: Nausea, The intensity of nausea on a 0-10 points visual analog scale, where 0 indicates no nausea and 10 worst imaginable nausea., 30, 60, 90, 120, and 150 minutes after the study drug administration|Systolic and diastolic blood pressure, The change in systolic and diastolic blood pressure compared to baseline., 30, 60, 90, 120, and 150 minutes after the study drug administration|Heart rate, The change in heart rate compared to baseline., 30, 60, 90, 120, and 150 minutes after the study drug administration.
Sponsor/Collaborators: Sponsor: University of Tartu | Collaborators: Tartu University Hospital
Gender: MALE
Age: ADULT
Phases: PHASE4
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2023-04-17
Completion Date: 2023-12-31
Results First Posted:
Last Update Posted: 2023-06-12
Locations: Tartu University Hospital, Tartu, 50406, Estonia
URL: https://clinicaltrials.gov/show/NCT05804513